Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008463
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2001-01-09
Brief Title:
A Comparison of the Effectiveness Safety and Tolerability of Two Different Hepatitis C Treatments in Patients Infected With Both HIV and Hepatitis C Virus HCV
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Prospective Multicenter Phase IIIII Open-Label Controlled Randomized Trial Evaluating the Efficacy Safety and Tolerability of Interferon-alfa-2a Plus Ribavirin Versus PEG-interferon-alfa-2a Plus Ribavirin for Chronic Hepatitis C Virus HCV Infection in Individuals Co-Infected With Human Immunodeficiency Virus-1 HIV-1
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to see if treatment with PEG-interferon-alfa-2a PEG-IFN plus ribavirin is a more effective treatment for hepatitis C virus HCV than interferon-alfa-2a IFN plus ribavirin for patients infected with both HCV and HIV The study will also compare the 2 regimens to see which has fewer side effects
HCV infection is common in patients infected with HIV Patients infected with both HIV and HCV viruses seem to have more severe hepatitis C A combination of IFN and ribavirin has been shown to lessen the severity of HCV PEG-IFN is a modified form of IFN that stays in the blood longer which means that patients would not have to take the treatment as often This study will compare the safety and effectiveness of PEG-IFN to IFN when each is combined with ribavirin
HCV infection is common in patients infected with HIV Patients infected with both HIV and HCV viruses seem to have more severe hepatitis C A combination of IFN and ribavirin has been shown to lessen the severity of HCV PEG-IFN is a modified form of IFN that stays in the blood longer which means that patients would not have to take the treatment as often This study will compare the safety and effectiveness of PEG-IFN to IFN when each is combined with ribavirin
Detailed Description:
Infection with HCV is common in patients infected with HIV owing to similar routes of transmission The cellular immunosuppression caused by HIV infection appears to lead to an increased HCV plasma load more progressive liver disease and in patients with chronic hepatitis C increased mortality Ribavirin treatment combined with IFN has shown improved sustained virologic response rates over IFN monotherapy PEG-IFN a chemically modified formulation of IFN circulates for a much longer time in the blood than the parent compound Pharmacokinetic and pharmacodynamic data suggest that PEG-IFN injected weekly would have the potential for superior efficacy as compared with IFN injected 3 times per week The efficacy and safety profiles of combination therapy with PEG-IFN and ribavirin are not well known This study will compare combination therapy consisting of PEG-IFN and ribavirin with that of IFN and ribavirin
Patients are stratified according to HCV genotype and CD4 count and viral load then randomized to either Arm A IFN plus ribavirin or Arm B PEG-IFN plus ribavirin Patients receive up to 48 weeks of treatment Virologic response is assessed at Week 24 and a decision to continue or discontinue treatment is made If a virologic response is shown at Week 24 the patient continues treatment for an additional 24 weeks If no virologic response is observed then the histologic response is assessed by a liver biopsy If biopsy shows a histologic response is present treatment is continued for 24 weeks If biopsy shows no histologic response treatment is discontinued AS PER AMENDMENT 072001 Patients with virologic response who discontinue after Week 24 will have liver biopsy at time of discontinuation Patients with no virologic response continuing study treatment after having a liver biopsy within 2 weeks of Week 24 who also demonstrate histologic response and decide to discontinue after Week 24 are strongly encouraged to have a 2nd liver biopsy at the end of treatment Patients with no virologic response who discontinue after Week 24 will not have liver biopsy at time of discontinuation Physical examinations are done regularly and blood samples collected for routine laboratory tests confidential genetic testing and to measure HCV and HIV-1 plasma viral loads Women able to become pregnant have regular pregnancy tests All patients are followed for an additional 24 weeks after treatment discontinuation
Patients may enroll in 1 or none of the following substudies A5091s Hepatic C Viral Kinetics in Subjects Co-infected with Human Immunodeficiency Virus-1 HIV-1 and Hepatitis C Virus Genotype 1 HCV-1 AS PER AMENDMENT 072001 The following text has been deleted or A5092s Evaluation of the Effects of Ribavirin on Zidovudine ZDV or Stavudine d4T Triphosphate Formation AS PER AMENDMENT 072001 Substudy A5092s Evaluation of the Effects of Ribavirin on Zidovudine ZDV or Stavudine d4T Triphosphate Formation is now a stand-alone study
Patients are stratified according to HCV genotype and CD4 count and viral load then randomized to either Arm A IFN plus ribavirin or Arm B PEG-IFN plus ribavirin Patients receive up to 48 weeks of treatment Virologic response is assessed at Week 24 and a decision to continue or discontinue treatment is made If a virologic response is shown at Week 24 the patient continues treatment for an additional 24 weeks If no virologic response is observed then the histologic response is assessed by a liver biopsy If biopsy shows a histologic response is present treatment is continued for 24 weeks If biopsy shows no histologic response treatment is discontinued AS PER AMENDMENT 072001 Patients with virologic response who discontinue after Week 24 will have liver biopsy at time of discontinuation Patients with no virologic response continuing study treatment after having a liver biopsy within 2 weeks of Week 24 who also demonstrate histologic response and decide to discontinue after Week 24 are strongly encouraged to have a 2nd liver biopsy at the end of treatment Patients with no virologic response who discontinue after Week 24 will not have liver biopsy at time of discontinuation Physical examinations are done regularly and blood samples collected for routine laboratory tests confidential genetic testing and to measure HCV and HIV-1 plasma viral loads Women able to become pregnant have regular pregnancy tests All patients are followed for an additional 24 weeks after treatment discontinuation
Patients may enroll in 1 or none of the following substudies A5091s Hepatic C Viral Kinetics in Subjects Co-infected with Human Immunodeficiency Virus-1 HIV-1 and Hepatitis C Virus Genotype 1 HCV-1 AS PER AMENDMENT 072001 The following text has been deleted or A5092s Evaluation of the Effects of Ribavirin on Zidovudine ZDV or Stavudine d4T Triphosphate Formation AS PER AMENDMENT 072001 Substudy A5092s Evaluation of the Effects of Ribavirin on Zidovudine ZDV or Stavudine d4T Triphosphate Formation is now a stand-alone study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AACTG A5071 | Registry Identifier | DAIDS ES Registry Number | None |
| 10675 | REGISTRY | None | None |
| Substudy AACTG A5091s | None | None | None |
| ACTG A5071 | None | None | None |